NEWS!

100th Patient in EMBRACE II. ARN2007 was registered for the EMBRACE II Study last week and is the 100th Patient enrolled for the Study. This milestone has been reached quite quickly, so let's keep the momentum going.

Save the dates! The EMBRACE II Annual Meeting 2018 is planned for Friday 23rd and Saturday 24th March, 2018 in Vienna. At this stage, you don't need to do anything. This note will be updated and you will be sent an email when registration begins.

New CRF: Please make sure you use the latest version of the main CRF form. It should be the July 2013 version available in the Appendix section.

Important New Updates to Database. First, the Off-study form has been updated to include the option "Major Protocol Violation". When this is selected then further follow-ups are blocked and no further action needs to be taken for this patient. One example of when this should be used is when no BT was given. Second, the follow-up timeframe has been increased to 10 years.

What is EMBRACE?

EMBRACE is a study on MRI guided brachytherapy (BT) in locally advanced cervical cancer. Today point-based two-dimensional BT is most often used for definitive radiotherapy in cervical cancer. However, MRI guided 3D brachytherapy is increasingly being used in several centres, and the results reported so far are very promising. The major advantage of this technique is the possibility to conform the dose given by BT with regard to both volume (3D) and time (4D). Thus, by repetitive imaging performed before each BT implant it is possible to adapt the dose given by BT to the anatomy of each individual patient taking into account not only the position of organs at risk but also the tumour regression which often is obtained by preceding external beam radiotherapy and chemotherapy. Based on the experience collected so far, the image based BT approach significantly improves the DVH parameters and the improved dose delivered seems to have a major impact on the clinical outcome with a concomitant decrease in the rates of both local failure and morbidity.

The aim of the EMBRACE protocol is to introduce MRI based brachytherapy in a multicenter setting within the frame of a prospective observational study and to correlate image based DVH parameters for the clinical target volume and for organs at risk with outcome. Based on these results, we hope to develop prognostic and predictive statistical models for clinical outcomes including volumetric, dosimetric, clinical and biological risk factors as well as radiobiological parameter estimates that will allow a precise risk assessment in individual patients and aid in the development of new treatment protocols.

Patient registration and reporting will be performed via the internet to a central database accessible for registered investigators through this website. The study coordinator are Richard Pötter (Vienna), Jacob Chr. Lindegaard (Aarhus), Kari Tanderup, (Aarhus) and Christian Kirisits (Vienna). If you would like to hear more about the possibilities to participate in this trial, please contact Ian Dilworth at the study office in Vienna.